BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7700554 · Received July 18, 2018

    Report

    Report Number
    1920898-2018-00511
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 30, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382904916015
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: MALE. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7170874. CUSTOMER STATES THAT THE BARREL IS BOWED AND ALSO WITH A PORTION OF THE GRADUATION SCALE ERASED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BOWED/DENTED BARREL. THE SAMPLE ALSO EXHIBITED PART OF THE SCALE MISSING RANGING FROM THE 15-25 UNIT MARKINGS. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 03AUG2018 FOR FURTHER REVIEW. ON 07AUG2018, HOLDREGE RECEIVED ONE (1) 0.3ML, 6MM, 31G SYRINGE IN AN OPENED POLYBAG FROM BATCH# 7170874. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. THE SURFACE OF THE BARREL WAS EXAMINED AND IT WAS NOTED THAT NO EVIDENCE OF SCALE PRINT ON THE OPPOSITE SIDE OF THE SYRINGE BARREL FROM THE CRACK/DAMAGE WAS NOTED. POTENTIAL ROOT CAUSE FOR THE BOWED BARREL IS A JAM AT THE INFEED DIAL INTO THE PRINTER, POSSIBLY BY AN INHIBITOR GATE, RESULTING IN THE DAMAGE TO THE BARREL SYRINGE WALL. THE RESULTING BOW TO THE BARREL COULD POTENTIALLY HAVE CAUSED A MISPRINT ON THE BARREL, AS THE EXTERIOR SURFACE OF THE SYRINGE BARREL IS NO LONGER UNIFORM. THIS WOULD INCREASE THE POSSIBILITY OF AN INCOMPLETE 'KISS' OF THE PAD ON THE PRINTER TO THE SYRINGE BARREL SURFACE. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7170874 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF ANY CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7170874 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200707042] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200706680, 200706679] NOTED FOR SCRATCHED PRINT. THERE WAS ONE (1) NOTIFICATION [200706782] NOTED FOR INK SMEARS. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING DEFECTIVE ON LOT # 7170874 AND THE 1ST RELATED COMPLAINT FOR BOWED ON LOT # 7170874. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGES WERE BOWED AND HAD MISSING GRADUATION SCALES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGES WERE BOWED AND HAD MISSING GRADUATION SCALES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540338 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7170874 00382904916015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other